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# ‘Objectionable Conditions’ at BTS Research
- URL: https://www.fdaweb.com/objectionable-conditions-at-bts-research/
- Published: 2023-10-31T12:00:00.000Z
- Updated: 2026-09-14T14:14:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155678

A 6/27-7/8/22 FDA Bioresearch Monitoring Program inspection at Samm Solutions, doing business as BTS Research in San Diego, CA, identified objectionable conditions in the company’s role as the testing facility in two nonclinical laboratory studies. A 10/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/samm-solutions-inc-dba-bts-research-663898-10202023?ref=fdaweb.com) says FDA emphasized:

- the study director failed to assure that all experimental data were accurately recorded and verified and failed to assure unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented;
- the study director failed to authorize all deviations in the study from standard operating procedures and ensure the deviations were documented in the raw data;
- the final study report did not include a description of all circumstances that may have affected the quality and integrity of the data;
- the quality assurance unit failed to assure that the reported results in the final study report accurately reflect the raw data of the nonclinical laboratory study; and
- the study director failed to assure that all raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.

Samm Solutions was told to respond with a list of the specific actions it has taken to prevent similar violations in the future.